The botanical genus Cannabis includes the species indica and sativia. Within these species multiple distinct varieties and strains have been and continue to be developed. The genus known produce more than 480 different chemical substances. Among these chemicals approximately 80 distinct entities exist which are classified as cannabinoids. The two species differ in the amount of tetrahydrocannabinol (THC) produced. Cannabis sativia produces higher levels of THC. The psychotropic affects associated with THC have made the sativia species preferred as a recreational substance and for medicinal use where the psychotropic effect is desired. Not-with-standing THC and other chemical entities produced by the sativia species have significant and diverse pharmacological action.
The indica species is cultivable in cooler climates and produce more cannabidiol (CBD) than THC. This allows production of extracts with low THC. The seeds from Cannabis species are used to produce hemp oil which is used industrially and also as a nutritional supplement.
Cannabis derived materials which may contain THC and CBD in addition to numerous natural substances produced by the plants have been reported to have diverse pharmacological activities that include analgesic, anti-inflammatory, anti-cancer, antibiotic, and anti-oxidant activity.
In most jurisdictions throughout the world, including the United States, cannabinoids (which include THC, structurally related compounds, and in some instances CBD) are controlled substances and use for medical purposes has been discouraged. Since some products derived from cannabis species are economically important (e.g. hemp oil) maximum levels for cannabinoids in products have been set. In Canadian hemp seed oil THC levels are usually below detection limit of 4 ppm (parts per million, or 4 mg/kg). Legal limit for THC content in foodstuffs in Canada is 10 ppm. Some European countries have limits of 5 ppm or none-detected, some EU countries do not have such limits at all.
Relaxation of laws limiting the use of marijuana and thus cannabinoid containing products, in some jurisdictions (e.g. as of 2013 medical marijuana is considered legal in 20 states and the District of Columbia) has opened the door to encourage development of new cannabinoid containing products. To a large extent major focus has been directed at systemically administered formulations and formulations taking advantage of psychotropic activities or use of cannabinoids as antioxidants and neuroprotectants.
U.S. Pat. No. 6,630,507, incorporated herein by reference, discloses pharmaceutical compounds and compositions that are useful as tissue protectants, such as neuroprotectants and cardioprotectants. The compounds and compositions are disclosed to be used in the treatment of acute ischemic neurological insults or chronic neurodegenerative diseases. The disclosed compositions include cannabidiol and other cannabinoids, and the compositions are disclosed to include THC in amounts that do not promote psychoactive or psychotoxic effects. Accordingly, there is no disclosure of topical compositions that include THC in amounts that exceed the detection limit of THC.
In view of the foregoing, there is a need for topical formulations that comprise a Cannabis derived botanical drug product that take advantage of diverse pharmacologic activities, that are beyond and unforeseen from those described in U.S. Pat. No. 6,630,507 B1, in treatment of dermatologic and other diseases. We also define that the major cannabinoids are present in our products at concentrations exceeding the commonly applied maximum levels that define cannabis derived products, such as hemp oil, legal for non-drug use can provide unexpected and highly beneficial treatments for a wide variety of diseases.